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临床试验/NCT01872767
NCT01872767已完成不适用

Spectrum, Profile and Outcome of Infections in Patients With Cirrhosis and/ or Acute on Chronic Liver Failure Admitted in Liver Specialty ICU (Intensive Care Unit)- An Observational Study

Institute of Liver and Biliary Sciences, India1 个研究点 分布在 1 个国家目标入组 522 人开始时间: 2013年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
522
试验地点
1
主要终点
Mortality within 1 month during ICU (Intensive Care Unit) stay.

研究概览

简要总结

After successful screening diagnosis of cirrhosis and/or acute or chronic liver failure will be made. These patients will undergo detail clinical, biochemical and microbiological examination at baseline. Clinical examination and Biochemical evaluation will be done daily and signs of infection will be noted. Patients will undergo microbiological screening for infection every 48 hours. Patients suspected or diagnosed to be suffering from infections will be treated as per ILBS (Institute of Liver and Biliary Sciences) antibiotic policy. Site and etiology (bacterial and/or fungal) of infections will be noted in all patients at admission in liver specialty ICU (Intensive Care Unit) and during the ICU (Intensive Care Unit) stay. All the patients will be followed until discharge or death in ICU (Intensive Care Unit).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A clinical, radiological or histological diagnosis of cirrhosis and/or ACLF (Acute on Chronic Liver Failure).
  • Age > 18years

排除标准

  • Previous liver transplantation.
  • Patients who died within 8 hours of ICU (Intensive Care Unit) admission.
  • Acute liver failure
  • Lack of consent
  • Patient on steroids/ or any other immunosuppressive medication

结局指标

主要结局

Mortality within 1 month during ICU (Intensive Care Unit) stay.

时间窗: 30 days

次要结局

  • Number of days stayed in ICU (Intensive Care Unit).(30 days)
  • Proportion of patients with organ failure.(30 days)
  • Risk factors determination in development of multidrug resistance bacteria.Risk factors are defined as Nosocomial infection,Recent Hospitalization, recent antibiotic usage, SBP (spontaneous bacterial peritonitis)prophylaxis, diabetes etc(30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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